Eurofins Optimed - the leading partner in Early Clinical Development

By Dr Yves Donazzolo, Eurofins Optimed, CEO & Medical Director  yvesdonazzolo@eurofins.com

Early Clinical Stages are critical in the development process to get an excellent evaluation of the safety and the efficacy of a new compound. Biotech,Medtech, big pharma and agro-food industries all need reliable partners to organise these key trials. Starting a clinical programme is always a source of anxiety for the investors and the decision makers. And expertise focused on early stages has many advantages in terms of quality, flexibility, respect of timelines and cost savings.

For 25 years, Eurofins Optimed has organised hundreds of clinical trials to support the development plans and to give accurate advice to countless R&D teams. As a leading partner, Eurofins Optimed specialises in First-Into- Human, Proof-Of-Concept, PK/PD and interactions studies.

Eurofins Optimed runs its own Clinical Pharmacology Unit in France with a dedicated team and an up-to-date equipment. Many studies involving healthy volunteers or ambulatory patients are conducted there.

Access to patients is key, and Eurofins Optimed organises the trials in many hospitals and medical centres in Europe, Western and Eastern countries.

In close collaboration with the other Eurofins sites (GMP, GLP, bioanalysis, central laboratories), Eurofins Optimed ensures a smooth process and coordination of all the stakeholders of the trials (investigators, pharmacy, monitoring, laboratories, imaging, ECG, etc.).

As data collection and data management also represent integral components of a clinical trial, Eurofins Optimed offers a global data management solutions, including database set-up, eCRF, EDC, coding or CDISC export in the Oracle Clinical® environment. Statistical analysis is then performed using SAS® in a secured and validated process.

Having earned ISO 9001:2008 certification to deliver high-standard services, the team at Eurofins Optimed is client-oriented and recognised as a leading and reliable partner for the global project management in early stages of the clinical evaluation of new compounds.

For more information, visit www.eurofinsoptimed.com or send an email to optimed@eurofins.com.